Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder (EYIPTSD)
19. marts 2013 opdateret af: Sat Bir Khalsa, PhD, Brigham and Women's Hospital
The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group.
Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Specific Aims:
- To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline evaluation and to a waitlist control group.
- To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
- To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
- To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
108
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Brigham and Women's Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male and female military veterans and active duty military personnel aged 18 and older
- A DSM IV diagnosis of post-traumatic stress disorder
- Potential subjects on medications are eligible to participate in the study
- Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
- Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process
Exclusion Criteria:
- Potential subjects are ineligible if pregnant and in their third trimester.
- Potential subjects are ineligible if they are confined to a wheel chair.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Yoga behandling
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The 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions.
In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home.
Andre navne:
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Ingen indgriben: Waitlist
Waitlist control, no active treatment, treatment as usual, active treatment offered after waitlist control period.
This study began as a single arm treatment trial and then transitioned to a randomized controlled trial.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Clinician Administered PTSD Scale (CAPS)
Tidsramme: pre-intervention and 10 weeks
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pre-intervention and 10 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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PTSD Checklist Military Version (PCL-M)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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Impact of Events Scale - Revised (IES-R)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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25-item Resilience Scale (RS)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
|
Twenty-four-hour urinary samples
Tidsramme: pre-intervention and 3 months post intervention
|
pre-intervention and 3 months post intervention
|
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10-minute segment of a seated 30-minute electrocardiogram recording session
Tidsramme: pre-intervention and 3 months post intervention
|
pre-intervention and 3 months post intervention
|
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Beck Depression Inventory (BDI)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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Spielberger State Trait Anxiety Inventory (STAI)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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Daily Sleep Wake Diaries
Tidsramme: during intervention (weeks 1-10) and 3 months post intervention
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during intervention (weeks 1-10) and 3 months post intervention
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Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Credibility Expectancy Questionnaire (CEQ)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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Body-Oriented State Questionnaire (BOSC)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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5-Facet Mindfulness Questionnaire (FFMQ)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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Perceived Stress Scale (PSS)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
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Yoga Follow-up Questionnaire
Tidsramme: 3 months post intervention
|
3 months post intervention
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PTSD Checklist Civilian Version (PCL-C)
Tidsramme: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
|
pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sat Bir S Khalsa, Ph.D., Brigham and Women's Hospital
- Studieleder: Jennifer Johnston, MA, LMHC, Northeastern University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
- van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.
- van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J. Disorders of extreme stress: The empirical foundation of a complex adaptation to trauma. J Trauma Stress. 2005 Oct;18(5):389-99. doi: 10.1002/jts.20047.
- Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med. 2001 Oct;31(7):1237-47. doi: 10.1017/s0033291701004287.
- Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.
- Morse DR, Cohen L, Furst ML, Martin JS. A physiological evaluation of the yoga concept of respiratory control of autonomic nervous system activity. Int J Psychosom. 1984;31(1):3-19. No abstract available.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2009
Primær færdiggørelse (Faktiske)
1. maj 2012
Studieafslutning (Faktiske)
1. maj 2012
Datoer for studieregistrering
Først indsendt
13. august 2009
Først indsendt, der opfyldte QC-kriterier
18. august 2009
Først opslået (Skøn)
20. august 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. marts 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. marts 2013
Sidst verificeret
1. marts 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009-P-000717
- 08144033
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .